MAUDE Adverse Event Report: Medtronic Navigation, Inc. AQUAMANTYS 6.0 BIPOLAR SEALER; ELECTROSURGICAL, CUTTING & COAGULATION & ACCES

Model Number	23-112-1
Medical Device Problem Codes	Smoking (1585); Noise, Audible (3273)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/22/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received from healthcare provider (hcp) via a manufacturer representative regarding a handpiece.It was reported that during an above-the-knee amputation procedure, a generator produced a loud noise during activation (other case).The generator was switched out intraoperatively, and a similar loud noise was observed with the replacement generator during activation while using the same device.A loud pump noise was also reported to be always present when the handpiece was activated.The generator was then reported to have started ¿smoking¿ while the button was pressed, and use of the device was discontinued intraoperatively after the smoking was observed.The machines were changed during the case and the device was re-primed, and the procedure was completed without further use of the device.Patient was present and unknown patient impact.Additional information was received.It was reported that the generator would not pump fluid.The cause of the noise was the bad tubing of the handpiece.The handpiece was not stopped immediately after the noise was heard; use continued until it started smoking.The noise continued during use and activation, not just during initial priming.There was no patient impact.
Additional Manufacturer Narrative
(h3): no parts have been received by the manufacturer for evaluation.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: AQUAMANTYS 6.0 BIPOLAR SEALER
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCES
• Manufacturer (Section D): Medtronic Navigation, Inc.; 200 medtronic drive; lafayette CO 80026
• Manufacturer (Section G): Medtronic Navigation, Inc.; 200 medtronic drive; lafayette CO 80026
• Manufacturer Contact: justin ellis ; 8200 coral sea street ne mvs21; mounds view, MN 55112 ; +1(763)526-5677
• MDR Report Key: 50433970
• Report Number: 1723170-2026-01202
• Device Sequence Number: 10370877
• Product Code: GEI
• UDI-Device Identifier: 00763000738501
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K052859
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/25/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 23-112-1
• Device Catalogue Number: 23-112-1
• Device Lot Number: AQ26031891
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/29/2026
• Initial Report FDA Received Date: 08/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/19/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown